The Head of IVD Program Development (HPD) will manage a large program focused on developing innovative molecular diagnostic systems for point-of-care testing of infectious diseases. The HPD will work with country teams in Europe and the US and lead a complex IVD product program. Coordinate, communicate, and lead project / Core teams, utilizing design controls and project management processes in a regulated environment to successfully develop and transition programs from design through commercialization. This program involves both internal and external partner solution elements. This HPD will also oversee the overall solution integration and delivery.
The role requires the ability to cultivate and sustain relationships across levels of seniority, and exceptional qualitative and quantitative analytical abilities. Time management, task prioritization, team leadership, and communication skills are essential, as is a commitment to excellence.
Recognized authority internally and externally on leading-edge technologies, theories, or techniques. Provides innovative solutions to complex and critically sensitive issues affecting multiple disciplines and work groups. Determines and pursues courses of action essential in accomplishing objectives. Integrates advanced technology, theories or techniques that have a significant continued impact across disciplines and business units. Serves as organization spokesperson on specialized projects or programs. Champions large projects that affect the company's long-range goals and objectives. Provides mentoring and guidance to lower-level employees.
Responsibilities:
* Craft and execute comprehensive work-plans with various country teams across different technical fields spanning from Assay development, Hardware and Software engineering as well as designing microfluidic consumables.
* Manage the program from design concepts and feasibility throughout development, verification & validation, design transfer and start of production.
* Lead a cross functional product development core team in the execution of deliverables. Work closely with Operations, Purchasing, Quality, Marketing, Regulatory, Legal, and other functions to ensure project priorities and decisions are consistent and accurate between teams and corporate strategic plans.
* Lead a cross functional joint project team with external partners to align and execute the project per contractual milestones.
* Communicate program updates to the core team, to functional management and to executive leadership both internally and externally.
* Ensure timely team completion of documents required for the product design history file.
* Ensure sufficient resources are identified and allocated to the program.
* Manage program by establishing goals and delivery plan, supervising task execution, and monitoring project progress to ensure that expected deliverables and targets are achieved on time and on budget.
* Lead the team to prepare for phase gate reviews and other go/no go decisions required by executive leadership.
* Provide a single point of contact for upper management and providing program leadership during the development efforts.
* Provide guidance in development, implementation and management of development programs consistent with organizational and industry best practices.
* This person may manage a small team of subject matter experts to help deliver the program.
Education and Experience Required:
* Master’s degree in engineering, science or related technical discipline, plus at least 15 years of work experience.
* Minimum of 10-years medical device and/or IVD product development experience, including Molecular Diagnostics.
* Experience in Assay Development.
* Requires program manager experience from concept to initial commercialization for at least two medical or IVD devices; and, preferred at least one IVD medical device in Molecular Diagnostics.
* Experience working on regulated product developments (ideally IVDD 98/79/EG and/or FDA 510k) and QMS according to ISO 13485 or similar.
* Experience leading core teams to successfully launch medical devices or IVD products is highly desired.
* Experience compliantly navigating US health care laws.
* Experience in working with external suppliers, including ODM (Outsource Design and Manufacturing) partners.
* Experience managing and developing program plans and budgets.
* Experience successfully navigating cross-functional, matrixed organization.
* Skilled at identifying and consolidating complex, moving parameters across functions and product development.
* Ability to navigate processes with multiple stakeholders in various time zones.
* Ability to problem solve without extensive structural or operational support.
Knowledge and Skills:
* Recognized industry and company expert regarding development of project and program management standards, equipment, and methodologies.
* Integrating program management technologies, solutions, and practices into overall business architecture.
* Demonstrated strategic business acumen, innovation, and success, with multiple examples of managing cross-business unit and organization-wide programs.
* Outstanding analytical and problem-solving skills.
* Experience in overall architecture of electronic hardware, materials, and component design and manufacture for products and solutions.
* Excellent written and verbal communication skills; mastery in English and local language.
* Ability to effectively communicate program management architectures, plans, proposals, and results, and negotiate options at the most senior organizational levels.
Disclaimer:
This job description describes the general nature and level of work performed in this role. It is not intended to be an exhaustive list of all duties, skills, responsibilities, knowledge, etc. These may be subject to change and additional functions may be assigned as needed by management.
The base pay range for this role is $159,650 - $239,500 annually with additional opportunities for pay in the form of bonus and/or equity (applies to US candidates only). Pay varies by work location, job-related knowledge, skills, and experience.
Benefits:
HP offers a comprehensive benefits package for this position, including:
* Health insurance
* Dental insurance
* Vision insurance
* Long term/short term disability insurance
* Employee assistance program
* Flexible spending account
* Life insurance
* Generous time off policies, including;
o 4-12 weeks fully paid parental leave based on tenure
o 13 paid holidays
o Additional flexible paid vacation and sick leave (US benefits overview)
The compensation and benefits information are accurate as of the date of this posting. The Company reserves the right to modify this information at any time, with or without notice, subject to applicable law.
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